Quality Systems Engineer

DEKA Research and Development; Town of Berwick; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading company in medical device R&D is seeking a Quality Systems Engineer to enhance their Quality Management System. The role involves administering the QMS, training personnel, and supporting audits. Ideal candidates have a background in engineering or science and experience in regulated environments.

Qualifications

• 2+ years in QMS or document-centric environment with degree, or 3+ years without.
• Experience with documentation in a regulated field.

Responsibilities

• Administer the Quality Management System and review records.
• Act as Lead Training Coordinator and support audits.
• Use statistical tools to monitor and report quality metrics.

Skills

Communication

Multitasking

Statistical Analysis

Education

Engineering or Science Degree

Job description

DEKA R&D has an immediate opening for a Quality Systems Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality System Manager. This is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:

• Administer the (electronic) Quality Management System
• Review and Approve Quality System Records including Complaint records
• Process changes for QMS Procedures (SOPs)
  • • Make red-line changes
    • Make new master documents, archive and distribute via electronic system
    • Track training for QMS documents within the Change Order process
    • Track open impacts to completion
• Act as Lead Training Coordinator and CAPA Coordinator
• Administer the site calibration program
• Support the site Corrective and Preventive Action program
• File records manually and electronically
• Support QMS collection and trending of quality data
• Use statistical tools to monitor and report on quality metrics
• Manage QMS databases for action items and implementation
• Support vendor qualification and management
• Support external and internal audits
• Aid in the development of training programs
• Provide training as required to company personnel
• Generate quizzes or other methods to ensure competency following training

Skills needed to be successful:

• Preferred experience 2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 3+ years' QMS or document centric environment without degree
• Experience with documentation in a regulated field (medical device preferable)
• Prior auditing experience is a plus
• Strong written/verbal communication skills
• Ability to:
  • Learn custom software programs
  • Multitask and carry tasks through to completion
  • Manage multiple sources of data and develop reports